Drug Approval | March 02, 2022
Amneal enters U.S. biosimilars market with approval of Releukotm
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
First of three Amneal biosimilars expected for U.S. approval and launch in 2022
The products are based on a combination of mushrooms and cannabinoids that have achieved a strong therapeutic effect using low concentrations of THC. The treatment is expected to be launched in Israel, US and UK in H2 2022
First-of-its-kind precision medicine test to predict a cancer patient’s response to an Immune Checkpoint Inhibitor (ICI)
Keytruda plus Lenvima is also approved in the U.S. and Europe for the first-line treatment of adult patients with advanced RCC.
Enhertu is a HER2-directed antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
Tepmetko is the first and only oral MET inhibitor to be approved in the European Economic Area for treating adult patients with advanced NSCLC harboring alterations leading to METex14 skipping, who require systemic therapy following prior treatment
Application based on the pivotal Phase 3 TRANSFORM study in which Breyanzi showed significant and clinically meaningful improvements over salvage chemotherapy followed by high-dose chemotherapy plus autologous stem cell transplant, which has been the standard of care for more than 20 years
Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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